Congress and FDA Take Action to Combat Opioid Crisis

The House recently enacted multiple legislative proposals to support treatment of opioid abusers and deter inappropriate drug prescribing and illegal distribution. This bipartisan action sets the stage for similar action by the Senate, as the legislators seek to address the deadly drug epidemic before the November midterm elections. A main objective of these policies is to widen access to medications for addiction treatment and overdose emergencies, a strategy backed by pharma manufacturers of buprenorphine and newer rescue drugs and opioid disorder therapies. The legislation also encourages prescribing of non-opioid pain therapies but stops short of mandating prescriber education on pain management-or of regulating drug prices.

At the same time, the Justice Department brought charges against dozens of individuals involved in prescribing and distributing opioids and illegal narcotics as part of a massive healthcare fraud enforcement action across the country. Although most of the 600 defendants face charges related to schemes to bilk Medicare, Medicaid, and other government health programs of some $2 billion in fraudulent claims, the campaign also targeted opioid-related activities, with more than 70 doctors and other health professionals facing charges related to “fanning the flames of the opioid crisis.”

Shutting down websites

As part of ongoing FDA efforts to reduce illegal opioid prescribing and distribution, the agency seeks to curb the rise in opioid sales through online pharmacies. In June 2018, FDA sent warning letters to operators of 53 websites to halt illegal sales of unapproved, misbranded, and dangerous medicines such as Tramadol and oxycodone, or face product seizures or injunctions.

More recently, FDA hosted an “opioids summit” to discuss with leading Internet operators and other stakeholders ways to reduce the availability of opioids through misleading websites and search engines [see  ]. The agency cited a January 2018 report from the Senate Permanent Subcommittee on Investigation indicating that online illicit drug sales reached more than $150 million in 2015, as use of the Internet to purchase opioids from online pharmacies has soared. 

FDA invited leading tech companies to the summit, such as Facebook, Google, Microsoft, and Yahoo, as well as online shopping sites, shipping firms, payment processors, and trade associations representing online pharmacies and Internet operators. While the tech community maintains that online sales account for only a small portion of illegal drug transactions, FDA commissioner Scott Gottlieb called for concerted action: “We can’t just play whack-a-mole with illegal sites, shutting down URLs only to watch new ones pop up.” Cutting off the flow of illicit Internet traffic in opioids “is critical,” he said, urging attendees to work together to stop the “digital drug dealers.”

FDA has increased resources to target and take action against illicit Internet drug marketers, despite multiple challenges in doing so. For example, progress in educating health professionals on the importance of reducing prescribing of opioids in favor of less addictive pain medicines now is predicted to send even more individuals suffering from opioid addiction to websites and other sources of illegal and potentially unsafe pills.

Gottlieb acknowledged that the tech firms at the summit have “the expertise to transform this space.” He cited efforts by Google to de-index web pages linked to FDA warning letters, by Microsoft’s Bing to attach pop-up warnings to such illicit websites, and by Facebook to steer parties seeking opioids online to sites with information on addiction treatment. While there are difficulties associated with implementing these and other strategies, he urged further collaboration with Internet experts to devise technological solutions and collective approaches for decreasing opioid availability.